This phase II trial studies the effect of tocilizumab in preventing respiratory failure and death in patients with severe COVID-19 infection. Part of the complications from the COVID-19 infection may be due to the virus causing damage to the lungs, some of this damage may be caused by an extreme inflammatory reaction produced by the immune system as it tries to fight off the virus. A protein called IL-6 (interleukin 6) plays a major role in this type of inflammation. Tocilizumab may prevent IL-6 from attaching to cells. By blocking IL-6, tocilizumab may prevent damage to the lungs and reduce the need for treatment with a mechanical ventilator. If a patient is already receiving mechanical ventilation to assist with breathing, tocilizumab may improve the patient’s condition enough to allow this treatment to be stopped.
Additional locations may be listed on ClinicalTrials.gov for NCT04377659.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate the impact of tocilizumab administration on progression of respiratory failure in patients infected with severe COVID-19.
SECONDARY OBJECTIVES:
I. Overall survival.
II. Protocol-defined therapeutic response to tocilizumab.
III. Mechanical ventilation-free days (for both cohorts) at 4 weeks.
IV. To assess the safety of tocilizumab in patients with severe COVID-19 infection.
V. To assess treatment impact on CRP, IL-6 and cytokine levels, ferritin, lymphocyte phenotypes, coagulation parameters, immunoglobulin levels and antibody levels.
VI. To assess the impact on supplemental oxygen requirement, chest imaging and fever.
VII. To assess Sequential Organ Failure Assessment (SOFA) scores following tocilizumab administration in patients with severe COVID19 admitted to intensive care unit (ICU) who are intubated, on mechanical ventilation. (cohort 2)
VIII. To assess ability to produce antibody against SARS-CoV-2.
OUTLINE:
Patients receive tocilizumab intravenously (IV) on day 1. Patients whose condition is not improving and do not experience side effects to study drug, may receive a second dose between 1-5 days after first dose.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorBoglarka Gyurkocza
